New Chapter in the European Pharmacopoeia on Multivariate Statistical Process Control
Recommendation
28-30 April 2026
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
In past September you could already read about the draft of a new Ph. Eur. chapter (5.28) regarding Multivariate Statistical Process Control (please see New Ph. Eur. chapter on statistical process control (SPC) planned). The comment period ended in September 2019. Now, this chapter has been adopted and will be published in the October 2020 issue. It is the first time that this topic is included in a pharmacopoeia. The chapter provides an introduction to the topic, but will not become legally binding. The chapter includes:
- General Introduction
- Introduction to Statistical Process Control (SPC)
- Introduction to Multivariate Statistical Process Control (MSCP)
- Theoretical background
On the website of the European Directorate for the Quality of Medicines and HealthCare (EDQM) you can find more information on this chapter under "European Pharmacopoeia: Adoption of a new general chapter on Multivariate Statistical Process Control".
Related GMP News
22.04.2026Sampling: A Crucial Factor in Process Validation
22.04.2026Cleaning and Maintenance in the Focus of the FDA
15.04.2026Cleaning Validation Technical Guide - What Does China Expect in Terms of Cleaning Validation?
11.03.2026Risk Assessment as the Basis for Process Validation
25.02.2026Rationale for Limit Selection in Process Validation
25.02.2026The GMP Relevance of Equipment Maintenance from FDA's Perspective